Summary
This video explains the critical process of defining the reportable range for impurity during method validation, in accordance with the IC guideline Q2. It emphasizes the significance of establishing both low and high-end concentrations to ensure accurate and reliable results. The video also covers the calculation of impurities based on percent area, showcasing different methods like external standard and normalization calculations for thorough validation.
Defining Reportable Range for Impurity
Explanation of how to define reportable range for impurity during method validation, emphasizing the importance of range as an essential parameter for validation.
Understanding Reporting Ranges for Impurity Method Validation
Explanation of reporting ranges for impurity method validation according to the IC guideline Q2.
Defining Low-end Concentration
Discussion on how to define the low end of concentration, including guidance on considering a threshold to define the low end of the study.
Understanding High-end Concentration
Explanation of defining the high-end concentration by understanding acceptance criteria and specifications, particularly focusing on shelf life and release specifications.
Calculating Impurity Based on Percent Area
Explanation of calculating impurities based on the percent area, including discussions on external standard methods and normalization calculations.
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